Fatty acids, C6-19-branched, copper(2+) salts

Endpoint summary

Description of key information

No acute toxicity studies with fatty acids, C6-19-branched, copper(2+) salts are available, thus the acute toxicity will be addressed with existing data on the individual moieties copper and neoacids category substances.

Signs of acute oral toxicity are not expected for the moiety neoacids, since the LD50 is greater than 2000 mg/kg bw. The studies for moiety copper were assessed in a weight of evidence approach. The oral LD50 value is 197 mg Cu/kg bw. Further, copper sulphate is legally classified (Regulation 1272/2008; Index No. 029 -004 -00 -0) for acute oral toxicity category 4.

The calculated LD50 for fatty acids, C6-19-branched, copper(2+) salts is 300 < LD50 <= 2000, thus the substance is classified according to regulation (EC) 1272/2008 for acute oral toxicity category 4 (H302: Harmful if swallowed).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No acute toxicity studies with fatty acids, C6-19-branched, copper (2+) salts are available, thus the acute toxicity will be addressed with existing data on the dissociation products copper and fatty acids, C6-19-branched. According to the RAAF, neodecanoic is considered in place of fatty acids, C6-19-branched.

Copper

Acute oral toxicity

Three relevant and reliable GLP studies (Lheritier 1994, Sanders 2001a, Sanders 2002) tested different copper substances in regard to acute oral toxicity. All studies were used in a weight of evidence approach. Sanders (2002) assessed acute oral toxicity of copper oxide in rats conducting a OECD No.423 study. The test substance showed no systemic toxicity and an LD50 >2500 mg/kg bw was determined. In contrast, Lheritier (1994) and Sanders (2001a) showed comparable results in regard to acute oral toxicity for copper sulphate and coated copper flakes, respectively. In a OECD No. 401 study, Sanders (2001) estimated an LD50 value in rats to be in the range of 300-500 mg/kg bw. Lheritier (1994) determined an LD50, for copper sulphate, in rats of about 481-482 mg/kg bw in a OECD No. 401 study. 

 

Neodecanoic acid

Neodecanoic acid has a low potential for toxicity via the oral, inhalation, and dermal routes. 

Acute oral toxicity

Male and female rats were gavaged with neodecanoic acid at concentrations of 1, 1.5, 2, 3, or 4 ml/kg to assess acute oral toxicity.  All animals that died during the study did so within 3 days of exposure. Signs of toxicity included lethargy, hypothermia, piloerection, dyspnea, and ataxia. Based on these results, it is concluded that the LD50 is approximately 2.27 ml/kg (2066 mg/kg). 

 

Fatty acids, C6-19-branched, copper (2+) salts

The LD50 for fatty acids, C6-19-branched, copper(2+) salts is based on the LD50 values of the assessment entities copper and neoacids. Based on the oral LD50 value for copper of 197 mg Cu/kg bw and the oral LD50 values of neoacids (as representative of fatty acids, C6-19-branched) of >2000 mg/kg bw/day, the calculated LD50 for fatty acids, C6-19-branched, copper(2+) salts is 300 < LD50 <= 2000, thus the substance is classified according to regulation (EC) 1272/2008 for acute oral toxicity category 4 (H302: Harmful if swallowed).

For further information on the toxicity of the assessment entities, please refer to the relevant section in the IUCLID.

Justification for classification or non-classification

The calculated LD50 for fatty acids, C6-19-branched, copper(2+) salts is 300 < LD50 <= 2000, thus the substance is classified according to regulation (EC) 1272/2008 for acute oral toxicity category 4 (H302: Harmful if swallowed). No adverse effects were observed upon necropsy in the acute oral toxicity studies with the assessment entity copper or neoacids (as representative of fatty acids, C6-19-branched) that would justify a classification for specific target organ toxicity-single exposure.